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Keynote 590 trial11/11/2023 ![]() ![]() The primary end points of the trial included overall survival and progression-free survival, concludes Shah. KEYNOTE-590 (NCT03189719) was a randomized, double-blind, placebo-controlled phase III clinical trial of pembrolizumab plus 5-FU and cisplatin (FP) versus placebo plus FP as first-line (1L) treatment in patients with locally advanced unresectable or metastatic carcinoma of the esophagus and gastroesophageal junction. KEYNOTE-590 showed profoundly improved survival when pembrolizumab was added to cisplatin-fluoropyrimidine chemotherapy in ESCC patients with combined positive score. We review potential explanations for this result. However, on July 30, 2019, findings from KEYNOTE-181 led to the FDA approval of pembrolizumab for the treatment of patients with recurrent locally advanced or metastatic esophageal squamous cell carcinoma whose tumors express PD-L1 with a combine positive score of 10 or more.Īs such, the phase 3 KEYNOTE-590 study evaluated pembrolizumab further in combination with standard cisplatin plus 5-fluorouracil compared with placebo plus chemotherapy in the first-line setting for patients with locally advanced or metastatic esophageal carcinoma, Shah explains. The ATTRACTION-4 trial did not see a similar overall survival benefit, despite a clear improvement in progression-free survival. Importantly, a small and relatively negligible proportion of patients had missing PD-L1 CPS statuses (KEYNOTE-590, n 19 out of 749 2. The characteristics of the three studies are summarized in Table 1. Shah, MD, director of the Gastrointestinal Oncology Program within the Division of Hematology and Medical Oncology and the Center for Advanced Digestive Care at Weill Cornell Medical College/ NewYork-Presbyterian Hospital, discusses the rationale for the phase 3 KEYNOTE-590 trial in locally advanced or metastatic esophageal carcinoma.ĭata from earlier studies, including the KEYNOTE-180 and KEYNOTE-181 trials, showed modest activity with pembrolizumab (Keytruda) assecond- and third-line therapy in esophageal cancer. Pembrolizumab plus chemotherapy versus chemotherapy alone for first-line treatment of advanced oesophageal cancer (KEYNOTE-590): a randomised, placebo-controlled. Three trials, CheckMate-649, 2 KEYNOTE-062, 18 and KEYNOTE-590, 3 were included in this analysis. ![]()
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